Event Recap – What's On File Could Be On Trial: Mastering Document Risk

On May 5, 2025, Gardner Law hosted a live webinar titled “What’s on File Could Be on Trial: Mastering Document Risk,” presented by David Graham, Senior Counsel at Gardner Law. With more than 35 years of litigation experience spanning medical device, pharmaceutical, and food industries, David shared his insights on the legal risks associated with company documentation and practical strategies to mitigate them.

This first installment of a two-part series focused on the foundational legal structures surrounding documentation in FDA-regulated industries. David emphasized that documentation plays a pivotal role in litigation—not just as evidence but as a reflection of a company’s culture, competence, and credibility.

Key Topics Covered:

Why Documentation Matters

David outlined why maintaining accurate, well-organized documentation is essential beyond regulatory compliance: it helps companies tell their story in litigation, avoid sanctions, support regulatory audits, and defend or prosecute claims. Poor documentation practices can result in fines, sanctions, adverse evidentiary presumptions, or even case dismissals.

Spoliation of Evidence 

A core focus of the webinar was spoliation, the negligent or intentional destruction of evidence relevant to litigation. David discussed the legal duty to preserve documents when litigation is threatened or foreseeable, briefly touching on recent case law examples, and the severe consequences of failing to preserve evidence—including adverse inference instructions or dismissal of claims.

Privilege and Confidentiality

David provided a practical overview of attorney-client privilege and work product doctrine, stressing the importance of designating privileged documents appropriately and maintaining their confidentiality. He explained how improper dissemination or failure to mark privileged communications could result in privilege waiver.

Similarly, he highlighted the value of protecting confidential business information—such as trade secrets, research data, and customer lists—both in business operations and litigation. David walked through confidentiality designations, protective orders, and company policies to safeguard sensitive data.

Document Retention Policies and Employee Training

The webinar also stressed the need for clear document retention policies, regardless of company size. David encouraged companies to designate responsible personnel, monitor compliance, and train employees regularly to ensure proper creation, retention, and destruction of documents. He noted that well-executed policies not only facilitate business operations but also bolster a company’s credibility in court.

Throughout the session, David shared anecdotes from past cases—including an instance where allowing a judge to tour a client’s facility helped it dispel claims of negligence and strengthened the company’s legal defense.

Looking Ahead:

The webinar concluded with a preview of Part Two in the series, scheduled for May 13, 2025 at 12:00pm CDT. The next session will delve deeper into bad documents—what they are, how to avoid creating them, and strategies for addressing problematic communications. David will also explore best practices for communicating via email, text, and other platforms, as well as documenting complaints and resolutions.

You can watch the full session above and download the slides at the link below. And stay tuned for next week when we recap Part Two of What’s on File Could Be on Trial: Mastering Document Risk from David Graham.